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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00048958
Other study ID # CALGB-8461
Secondary ID NCI-2009-00494CD
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1984

Study information

Verified date August 2021
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9000
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct. 2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients. 3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).

Study Design


Intervention

Genetic:
cytogenetic analysis


Locations

Country Name City State
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Battle Creek Health System Cancer Care Center Battle Creek Michigan
United States Mountainview Medical Berlin Vermont
United States Mecosta County Medical Center Big Rapids Michigan
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States St. Joseph Medical Center Bloomington Illinois
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts
United States Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Graham Hospital Canton Illinois
United States Illinois CancerCare - Canton Canton Illinois
United States Southeast Cancer Center Cape Girardeau Missouri
United States Illinois CancerCare - Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Iowa Blood and Cancer Care Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States St. Luke's Hospital Cedar Rapids Iowa
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Batte Cancer Center at Northeast Medical Center Concord North Carolina
United States Danville Regional Medical Center Danville Virginia
United States St. Luke's Hospital Cancer Care Center Duluth Minnesota
United States Duke Cancer Institute Durham North Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Union Hospital of Cecil County Elkton Maryland
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States Evanston Hospital Evanston Illinois
United States McLeod Regional Medical Center Florence South Carolina
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Galesburg Clinic, PC Galesburg Illinois
United States Illinois CancerCare - Galesburg Galesburg Illinois
United States Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan
United States Cancer Centers of the Carolinas - Eastside Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Illinois CancerCare - Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States Illinois CancerCare - Kewanee Clinic Kewanee Illinois
United States Kinston Medical Specialists Kinston North Carolina
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Parvin Radiation Oncology Liberty Missouri
United States Illinois CancerCare - Macomb Macomb Illinois
United States McDonough District Hospital Macomb Illinois
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Illinois CancerCare - Monmouth Monmouth Illinois
United States OSF Holy Family Medical Center Monmouth Illinois
United States Camino Medical Group - Treatment Center Mountain View California
United States Mercy General Health Partners Muskegon Michigan
United States Long Island Jewish Medical Center New Hyde Park New York
United States Mount Sinai Medical Center New York New York
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States Callahan Cancer Center at Great Plains Regional Medical Center North Platte Nebraska
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States CCOP - Kansas City Prairie Village Kansas
United States Illinois CancerCare - Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Kaiser Permanente Medical Office -Vandever Medical Office San Diego California
United States Naval Medical Center - San Diego San Diego California
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough Maine
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Munson Medical Center Traverse City Michigan
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Washington Cancer Institute at Washington Hospital Center Washington District of Columbia
United States Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (41)

Baer MR, Stewart CC, Lawrence D, Arthur DC, Mrózek K, Strout MP, Davey FR, Schiffer CA, Bloomfield CD. Acute myeloid leukemia with 11q23 translocations: myelomonocytic immunophenotype by multiparameter flow cytometry. Leukemia. 1998 Mar;12(3):317-25. — View Citation

Baldus CD, Tanner SM, Ruppert AS, Whitman SP, Archer KJ, Marcucci G, Caligiuri MA, Carroll AJ, Vardiman JW, Powell BL, Allen SL, Moore JO, Larson RA, Kolitz JE, de la Chapelle A, Bloomfield CD. BAALC expression predicts clinical outcome of de novo acute myeloid leukemia patients with normal cytogenetics: a Cancer and Leukemia Group B Study. Blood. 2003 Sep 1;102(5):1613-8. Epub 2003 May 15. — View Citation

Bernstein SH, Brunetto VL, Davey FR, Wurster-Hill D, Mayer RJ, Stone RM, Schiffer CA, Bloomfield CD. Acute myeloid leukemia-type chemotherapy for newly diagnosed patients without antecedent cytopenias having myelodysplastic syndrome as defined by French-A — View Citation

Bloomfield CD, Byrd JC, Farag SS, et al.: Cytogenetics for treatment stratification in adult acute myeloid leukemia (AML). [Abstract] Ann Hematol 80 (Suppl 2): A-37, S10, 2001.

Bloomfield CD, Lawrence D, Byrd JC, Carroll A, Pettenati MJ, Tantravahi R, Patil SR, Davey FR, Berg DT, Schiffer CA, Arthur DC, Mayer RJ. Frequency of prolonged remission duration after high-dose cytarabine intensification in acute myeloid leukemia varies — View Citation

Bloomfield CD, Ruppert AS, Mrózek K, Kolitz JE, Moore JO, Mayer RJ, Edwards CG, Sterling LJ, Vardiman JW, Carroll AJ, Pettenati MJ, Stamberg J, Byrd JC, Marcucci G, Larson RA; Cancer and Leukemia Group B (CALGB) Study 8461. Core binding factor acute myelo — View Citation

Bloomfield D: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Ann Hematol 78 (Suppl 2): A-50, S13, 1999.

Blum W, Mrózek K, Ruppert AS, Carroll AJ, Rao KW, Pettenati MJ, Anastasi J, Larson RA, Bloomfield CD. Adult de novo acute myeloid leukemia with t(6;11)(q27;q23): results from Cancer and Leukemia Group B Study 8461 and review of the literature. Cancer. 200 — View Citation

Blum W, Mrozek K, Ruppert AS, et al.: Early allogeneic transplantation for adults with de novo acute myeloid leukemia presenting with t(6;11)(q27;q23): results from CALGB 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6543, 568s, 2004.

Byrd JC, Dodge R, Carroll A, et al.: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Blood 92 (10 Pt 1): A-1282, 312a, 1998.

Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cy — View Citation

Byrd JC, Lawrence D, Arthur DC, et al.: Acute myeloid leukemia (AML) patients with pre-treatment isolated trisomy 8 are rarely cured with chemotherapy: results of CALGB 8461. [Abstract] Proc Am Assoc Cancer Res 37: A-1286, 188, 1996.

Byrd JC, Lawrence D, Arthur DC, Pettenati MJ, Tantravahi R, Qumsiyeh M, Stamberg J, Davey FR, Schiffer CA, Bloomfield CD. Patients with isolated trisomy 8 in acute myeloid leukemia are not cured with cytarabine-based chemotherapy: results from Cancer and — View Citation

Byrd JC, Mrózek K, Dodge R, et al.: Pre-treatment cytogenetics predict initial induction success and overall survival in adult patients with de novo acute myeloid leukemia: results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-1912, 457a, 2001.

Byrd JC, Mrózek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Patil SR, Rao KW, Watson MS, Koduru PR, Moore JO, Stone RM, Mayer RJ, Feldman EJ, Davey FR, Schiffer CA, Larson RA, Bloomfield CD; Cancer and Leukemia Group B (CALGB 8461). Pret — View Citation

Byrd JC, Ruppert AS, Mrózek K, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Stamberg J, Koduru PR, Moore JO, Mayer RJ, Davey FR, Larson RA, Bloomfield CD. Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(1 — View Citation

Byrd JC, Weiss RB, Arthur DC, Lawrence D, Baer MR, Davey F, Trikha ES, Carroll AJ, Tantravahi R, Qumsiyeh M, Patil SR, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Extramedullary leukemia adversely affects hematologic complete remission rate and overal — View Citation

Caligiuri MA, Strout MP, Arthur DC, et al.: Rearrangement of ALL1 is a recurrent molecular defect in adult acute myeloid leukemia (AML) with normal cytogenetics that predicts a short complete remission (CR) duration. [Abstract] Proceedings of the American

Caligiuri MA, Strout MP, Lawrence D, Arthur DC, Baer MR, Yu F, Knuutila S, Mrózek K, Oberkircher AR, Marcucci G, de la Chapelle A, Elonen E, Block AW, Rao PN, Herzig GP, Powell BL, Ruutu T, Schiffer CA, Bloomfield CD. Rearrangement of ALL1 (MLL) in acute — View Citation

Cancer and Leukemia Group B 8461, Farag SS, Archer KJ, Mrózek K, Ruppert AS, Carroll AJ, Vardiman JW, Pettenati MJ, Baer MR, Qumsiyeh MB, Koduru PR, Ning Y, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Pretreatment cytogenetics add to other prognostic fa — View Citation

Chen H, Sandler DP, Taylor JA, Shore DL, Liu E, Bloomfield CD, Bell DA. Increased risk for myelodysplastic syndromes in individuals with glutathione transferase theta 1 (GSTT1) gene defect. Lancet. 1996 Feb 3;347(8997):295-7. — View Citation

Farag SS, Archer KJ, Carroll AJ, et al.: Isolated trisomy (IT) is an adverse prognostic factor in patients (pts) with AML: results from Cancer and Leukemia Group B (CALGB 8461). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-112

Farag SS, Archer KJ, Mrózek K, Vardiman JW, Carroll AJ, Pettenati MJ, Moore JO, Kolitz JE, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Isolated trisomy of chromosomes 8, 11, 13 and 21 is an adverse prognostic factor in adults with de novo acute myeloid — View Citation

Farag SS, Ruppert AS, Mrózek K, Mayer RJ, Stone RM, Carroll AJ, Powell BL, Moore JO, Pettenati MJ, Koduru PR, Stamberg J, Baer MR, Block AW, Vardiman JW, Kolitz JE, Schiffer CA, Larson RA, Bloomfield CD. Outcome of induction and postremission therapy in y — View Citation

Heinonen K, Mrózek K, Lawrence D, Arthur DC, Pettenati MJ, Stamberg J, Qumsiyeh MB, Verma RS, MacCallum J, Schiffer CA, Bloomfield CD. Clinical characteristics of patients with de novo acute myeloid leukaemia and isolated trisomy 11: a Cancer and Leukemia — View Citation

Heinonen K, Mrózek K, Lawrence D, et al.: Trisomy 11 as the sole karyotypic abnormality identifies a group of older patients with acute myeloid leukemia (AML) with FAB M2 or M1 and unfavorable clinical outcome. Results of CALGB 8461. [Abstract] Proc Am As

Heinonen K, Rao PN, Slack JL, Cruz J, Bloomfield CD, Mrózek K. Isochromosome 12p in two cases of acute myeloid leukaemia without evidence of germ cell tumour. Br J Haematol. 1996 Jun;93(3):677-80. — View Citation

Marcucci G, Archer KJ, Mrózek K, et al.: Abnormal karyotype during complete remission (CR) predicts short relapse-free survival (RFS) in acute myeloid leukemia (AML): results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-2421, 577a, 2001.

Marcucci G, Mrózek K, Ruppert AS, Archer KJ, Pettenati MJ, Heerema NA, Carroll AJ, Koduru PR, Kolitz JE, Sterling LJ, Edwards CG, Anastasi J, Larson RA, Bloomfield CD. Abnormal cytogenetics at date of morphologic complete remission predicts short overall — View Citation

Marcucci G, Mrózek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17. — View Citation

Marcucci G, Mrózek, K, Ruppert AS, et al.: t(8;21) Acute myeloid leukemia (AML) differs from inv(16) AML in pretreatment characteristics, outcome and prognostic factors predicting outcome: a Cancer and Leukemia Group B (CALGB) Study. [Abstract] Blood 104

Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.

Mrózek K, Heinonen K, Lawrence D, Carroll AJ, Koduru PR, Rao KW, Strout MP, Hutchison RE, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Adult patients with de novo acute myeloid leukemia and t(9; 11)(p22; q23) have a superior outcome to patients with ot — View Citation

Mrózek K, Heinonen K, Lawrence D, et al.: t(9;11)(p22;q23) confers better prognosis than other translocations of 11q23 in adults with de novo acute myeloid leukemia (AML): a Cancer and Leukemia Group B study. [Abstract] Cytogenet Cell Genet 77: A-P332, 13

Sekeres MA, Peterson B, Dodge RK, Mayer RJ, Moore JO, Lee EJ, Kolitz J, Baer MR, Schiffer CA, Carroll AJ, Vardiman JW, Davey FR, Bloomfield CD, Larson RA, Stone RM; Cancer and Leukemia Group B. Differences in prognostic factors and outcomes in African Americans and whites with acute myeloid leukemia. Blood. 2004 Jun 1;103(11):4036-42. Epub 2004 Feb 19. — View Citation

Slack JL, Arthur DC, Lawrence D, et al.: Secondary (2°) cytogenetic changes in acute promyelocytic leukemia (APL): prognostic importance and association with the intron 3 breakpoint of the PML gene. [Abstract] Proc Am Assoc Cancer Res 37: A-3815, 557, 199

Slovak ML, Bloomfield CD, Gundacker H, et al.: Acute myeloid leukemia (AML) with t(6;9)(p23;q34) defines a very poor risk leukemia subgroup with distinguishing clinicopathological features: a United States (US) Cytogenetics Intergroup Study of 62 AML and

Wetzler M, Dodge RK, Mrózek K, Carroll AJ, Tantravahi R, Block AW, Pettenati MJ, Le Beau MM, Frankel SR, Stewart CC, Szatrowski TP, Schiffer CA, Larson RA, Bloomfield CD. Prospective karyotype analysis in adult acute lymphoblastic leukemia: the cancer and — View Citation

Wetzler M, Dodge RK, Mrózek K, et al.: Karyotype change in adult acute myeloid leukemia (AML) at first relapse - CALGB 8461. [Abstract] Blood 96 (11 Pt 1): A-3046, 706a, 2000.

Wetzler M, Dodge RK, Mrozek K, et al.: Secondary chromosome aberrations in adult acute lymphoblastic leukemia (ALL) with t(9;22) - a Cancer and Leukemia Group B (CALGB) study. [Abstract] Blood 98 (11 Pt 1): A-466, 111a, 2001.

Wetzler M, Dodge RK, Mrózek K, et al.: Trisomy 8 represents a poor risk group in adult acute lymphoblastic leukemia (ALL): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 92 (10 Pt 1): A-914, 223a, 1998.

* Note: There are 41 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM Up to 10 years
Primary Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters Up to 10 years
Primary Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens Up to 10 years
Primary Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols Up to 10 years
Primary To correlate specific karyotype groups with multidrug resistance data Up to 10 years
Primary To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) Up to 10 years
Primary To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course up to 10 yeras
Primary To identify new chromosome abnormalities important in leukemogenesis Up to 10 years
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